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"Since we last communicated with our shareholders in late July, our team has achieved many significant milestones as we move into the first regulatory reviews for our PHP System and strive towards European commercialization in 2010," said Eamonn P. Hobbs, President & CEO. "Our most recent accomplishment is yesterday's closing of our common stock public offering, which raised more than $32.4 million and significantly improves our balance sheet. The successful offering met all of the key goals established by the Board of Directors and provides our company with the resources required to execute our regulatory approval and go-to-market strategies. We attracted several leading and internationally known institutional investors to the offering and we fully expect the transaction will shortly lead to new sell-side analyst coverage of the company," added Mr. Hobbs.
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Other recent highlights include:
"With the enrollment in our Phase III clinical study completed, we are now beginning to prepare our application to the FDA for marketing approval," said Mr. Hobbs. "We continue to expect that we will submit the application to the FDA by the end of the first half of 2010. Meanwhile, we are optimistic about our ability to gain CE mark approval in Europe in early 2010 and expect to begin commercial sales in the European markets shortly thereafter. With the proceeds from the offering boosting our cash balance to more than $37 million, and the potential opportunity to gain additional resources through international partnerships, we are very well positioned to execute on our strategies, expand the potential benefits of the PHP System to patients globally and build increasing returns to our shareholders."
About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical device company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of liver cancers. Delcath's novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer drugs to the liver while preventing these high doses of drug from entering the patient's bloodstream. The Company is currently enrolling patients in Phase III and Phase II clinical studies for the treatment of liver cancers using high doses of melphalan. The Company maintains a broad intellectual property portfolio on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website at www.delcath.com.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
-- Active negotiations continue with several international entities to provide exclusive geographic market rights for the PHP System. -- In early September, the Data and Safety Monitoring Board ("DSMB") reviewed clinical data on 77 patients enrolled in Delcath's pivotal Phase III clinical trial and unanimously recommended that the trial continue to enroll patients with the goal of reaching the 92 patients required to complete the study. -- In October, the pivotal Phase III Metastatic Melanoma Trial met its goal of 92 patients and was fully enrolled. This clinical study is evaluating the Delcath PHP System(TM) for the regional delivery of melphalan to the liver to treat patients with metastatic cutaneous and ocular melanoma who have unresectable tumors in the liver. -- Enrollment in the Phase II clinical study of the Delcath PHP System with melphalan for patients with inoperable liver metastases from neuroendocrine tumors has now reached 25 patients. The trial is continuing to enroll patients. The multi-arm trial is being conducted by the National Cancer Institute ("NCI") in Bethesda, Maryland. The trial is also enrolling patients suffering from primary liver cancer and metastatic adenocarcinomas (including colorectal cancer) and melanoma. The Company expects to update data from this study in the coming months. -- Completed the expansion of the executive management team with the additions of David McDonald, Chief Financial Officer; Dr. Krishna Kandarpa, Chief Medical Officer and Executive Vice President of Research and Development; Agustin Gago, Executive Vice President for Global Sales and Marketing; John Purpura as Executive Vice President for Regulatory Affairs and Quality Assurance; and Armand "Chuck" Frigon as Vice President for Operations. -- Established a low cost operations facility in Queensbury, New York in which Delcath plans to locate manufacturing of its PHP System.
SOURCE Delcath Systems, Inc.
